🇺🇸 Effexor in United States

FDA authorised Effexor on 20 October 1997 · 37,438 US adverse-event reports

Marketing authorisations

FDA — authorised 20 October 1997

  • Application: NDA020699
  • Marketing authorisation holder: UPJOHN
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Nausea — 4,886 reports (13.05%)
  2. Drug Ineffective — 4,517 reports (12.07%)
  3. Fatigue — 4,053 reports (10.83%)
  4. Depression — 3,878 reports (10.36%)
  5. Headache — 3,801 reports (10.15%)
  6. Anxiety — 3,746 reports (10.01%)
  7. Dizziness — 3,645 reports (9.74%)
  8. Pain — 3,072 reports (8.21%)
  9. Drug Withdrawal Syndrome — 2,922 reports (7.8%)
  10. Insomnia — 2,918 reports (7.79%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Effexor approved in United States?

Yes. FDA authorised it on 20 October 1997; FDA has authorised it.

Who is the marketing authorisation holder for Effexor in United States?

UPJOHN holds the US marketing authorisation.